NCT04139954

Brief Summary

In this study, investigators aimed to observe the examination findings, laboratory findings and drugs used in routine polyclinic controls of the participants using biological and targeted synthetic disease-modifying antirheumatic drug (DMARD) and the doses and side effects of these drugs. The aim of this registry is to evaluate the real-life data of participants receiving these medications. Analysis of treatment follow-up, drug changes, causes of change, treatment-related paradoxic / immune reactions, compliance with adult vaccination programs, nutritional profiles, presence of metabolic syndrome, fertility status, pregnancy outcomes, and vitamin D levels will be recorded in the outpatient clinic. Rheumatoid Arthritis Impact of Disease, Psoriatic Arthritis Impact of Disease (RAID and PSAID indexes), Work Productivity and Activity Impairment Questionnaire (WPAI), drug compliance, central sensitization and fall risk will be evaluated with verbal evaluation forms performed at policlinic controls in patients with spondyloarthritis and rheumatoid arthritis. It is planned to conduct scientific analyzes and publish on various subjects from the recorded information on this registration system. Patients using biological and targeted synthetic DMARD treatments are closely monitored and evaluated in many ways due to the risk profiles and various characteristics of the drugs. With this registry system, it is aimed to evaluate the real-life data of the participants using these drugs. Real-life data are very valuable in monitoring the disease and the drugs. The study is observational and there is no expected risk since no intervention is planned.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

September 1, 2019

Last Update Submit

October 25, 2019

Conditions

Rheumatoid ArthritisSpondyloarthritis

Outcome Measures

Primary Outcomes (3)

  • Disease activity RA

    DAS 28 score will be calculated (Sensitive and swollen joints, VAS pain score, patient's global assessment and CRP / ESH values will be used for scoring)

    24 weeks

  • Disease activity- SpA1

    ASDAS score will be calculated (Sensitive and swollen joints, VAS pain score, patient's global assessment and CRP / ESH values will be used for scoring)

    24 weeks

  • Disease activity-SpA2

    BASDAI score will be calculated

    24 weeks

Other Outcomes (46)

  • WPAI (Work Productivity and Activity Impairment Questionnaire)

    an average of 1 year

  • RAID (Rheumatoid Arthritis Impact of Disease Questionnaire)

    an average of 1 year

  • PSAID (Psoriatic Arthritis Impact of Disease Questionnaire)

    an average of 1 year

  • +43 more other outcomes

Study Arms (1)

Rheumatoid arthritis and Spondyloarthritis

Patients using Biological or Targeted Synthetic DMARDs

Other: There is no intervention in the study

Interventions

There is no intervention in the studyOTHER

There is no intervention in the study

Rheumatoid arthritis and Spondyloarthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of patients followed in rheumatology and physical medicine and rehabilitation clinics in tertiary hospitals.

You may qualify if:

  • Clinical diagnosis with rheumatoid arthritis or spondyloarthritis Receiving biological or targeted synthetic DMARD treatment

You may not qualify if:

  • Aged under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Ankara Numune Training and Education Hospital, Department of Physical Medicine and Rehabilitation

Ankara, Turkey (Türkiye)

RECRUITING

Ankara University, Faculty of Medicine, Department of Rheumatology

Ankara, Turkey (Türkiye)

RECRUITING

Gazi University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Department of Rheumatology

Ankara, Turkey (Türkiye)

RECRUITING

Akdeniz University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Antalya, Turkey (Türkiye)

RECRUITING

Antalya Training and Research Hospital Physical Medicine and Rehabilitation Clinic

Antalya, Turkey (Türkiye)

RECRUITING

Adnan Menderes University, Faculty of Medicine, Department of Rheumatology

Aydin, Turkey (Türkiye)

RECRUITING

Dicle University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Diyarbakır, Turkey (Türkiye)

RECRUITING

Istanbul Medipol University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

RECRUITING

Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation, Department of Rheumatology

Istanbul, Turkey (Türkiye)

RECRUITING

Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

RECRUITING

Celal Bayar University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Manisa, Turkey (Türkiye)

RECRUITING

Sakarya University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Sakarya, Turkey (Türkiye)

RECRUITING

Atatürk University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Sivas, Turkey (Türkiye)

RECRUITING

Karadeniz Technical University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Trabzon, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Bodur H, Yurdakul FG, Ataman S, Cay HF, Gurer G, Capkin E, Sezer I, Duruoz MT, Melikoglu MA, Rezvani A, Yagci I, Gogus F, Kamanli A, Akgul O, Cevik R. Where we are in treat to target era? Predictive factors for remission and drug switching in patients with axial spondyloarthritis: a real-life evidence from BioStaR nationwide registry. Clin Rheumatol. 2022 Jul;41(7):2053-2063. doi: 10.1007/s10067-022-06145-8. Epub 2022 Mar 30.

    PMID: 35353263DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone Diseases

Study Officials

  • Hatice Bodur, Prof Dr

    Turkish League Against Rheumatism

    STUDY DIRECTOR

  • Şebnem Ataman, Prof Dr

    Turkish League Against Rheumatism

    STUDY DIRECTOR

  • Fatma G Yurdakul, MD

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Özgür Akgül, AssocProf Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Erhan Çapkın, Prof Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Fatih Çay, AssocProf Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Remzi Çevik, Prof Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Tuncay Duruöz, Prof Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Feride Göğüş, Prof Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Gülcan Gürer, Prof Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Ayhan Kamanlı, Prof Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Meltem Alkan Melikoğlu, Prof Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • Aylin Rezvani, AssocProf

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • İlhan Sezer, Prof Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • İsmihan Sunar, MD

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

  • İlker Yağcı, Prof Dr

    Turkish League Against Rheumatism

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma G Yurdakul, MD

CONTACT

+905059254214fatmagulonder@gmail.com

Hatice Bodur, Prof Dr

CONTACT

+905054848496haticebodur@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor (Fatma Gül Yurdakul)

Study Record Dates

First Submitted

September 1, 2019

First Posted

October 25, 2019

Study Start

February 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2024

Last Updated

October 29, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

All of the collected data will be shared with investigators of the study

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After the end of the study

Locations

TU(14)